Self-priming, anti-free flow valve for infusion pumps

ABSTRACT

A self-priming IV set valve includes a connector including a valve element that is positioned inside of the connector, and a cap that is removably connected to the connector. When the cap is mounted to the connector a passageway is formed in the connector such that air and liquid are permitted to pass through the connector and into the cap whereupon a hydrophobic filter of the cap prevents the passage of liquid there through while the hydrophobic filter permits the passage of air out of the cap and into the atmosphere. When the cap is not mounted to the connector, the valve element of the connector is configured to open under pressure and close when pressure ceases. Also disclosed is a method of priming the IV set, a cap assembly for a self-priming IV set valve, and a connector for a self-priming IV set valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a divisional patent application of U.S.Non-Provisional patent application Ser. No. 13/524,520, filed Jun. 15,2012, which is incorporated herein by reference in its entirety for allpurposes.

FIELD OF THE INVENTION

This invention relates to a medical valve for an IV set.

BACKGROUND OF THE INVENTION

As disclosed in U.S. Pat. No. 5,954,696 to Ryan, which is incorporatedby reference herein in its entirety, an infusion intravenous (IV) setcan be used with an ambulatory infusion pump to deliver fluid from an IVbag within the infusion pump to a patient. Though termed an “IV set,”the set may be used for any type of vascular infusion.

Conventional infusion sets comprise clear, flexible medical gradetubing, terminating at one end in a bag spike, and terminating at theother end in a conventional Luer, or any other type of medicalconnector. A releasable clamp is positioned along the length of thetubing to prevent the inadvertent passage of fluid through the tubing.

In use, intravenous (IV) infusion sets are typically primed with fluidprior to use to ensure that all air has been removed from inside thetubing that is attached to the IV bag. The spiking and priming processtypically involves first closing a clamp that is mounted to the tubingand then spiking an IV bag with a bag spike or any other connector thatis attached to a proximal end of the tubing. The IV bag is then hungfrom a pole and the operator opens the clamp. The fluid then travelsthrough length of the tubing under gravity and travels beyond the openclamp. When reaching the distal end of the tubing, the operator closesthe clamp to stop the fluid. If the clamp is not completely closed, thenfluid may drip from the distal end of the tubing.

SUMMARY OF THE INVENTION

This invention (1) simplifies the process of priming the infusion set inan effort to save time especially if a number of bags need to be set-up,(2) either reduces or eliminates the fluid discharge from the end of theIV set during priming, (3) provides an anti-siphon feature to preventrunaway of fluid if the tubing clamp is not closed or the IV set isremoved or dislodged from the pumping mechanism in situations where theset is used in infusion pumps.

According to one aspect of the invention, a self-priming IV set valveincludes a connector (such as a Luer connector) and a valve elementpositioned within the connector. A proximal end of the connector isconnectable to the infusion set and a distal end of the connector isconnectable to a catheter or any other infusion line. A cap is mountedto the distal end of the connector creating a fluid passageway withinthe valve through which air and liquid can pass into the cap and onto ahydrophobic filter of the cap. The hydrophobic filter prevents thepassage of liquid there-through while the hydrophobic filter permits thepassage of air out of the cap and into the atmosphere. When the cap isnot mounted to the connector, the valve element within the connector isconfigured to open under pump pressure and close when pump pressureceases.

According to another aspect of the invention, a method of priming an IVset comprises the steps of connecting the cap to the connector therebyexposing a fluid passageway between the connector and the cap;delivering fluid including air and liquid through the tubing, into theconnector, through the fluid passageway, into the cap and onto ahydrophobic filter of the cap thereby preventing the passage of liquidthrough the hydrophobic filter while permitting the passage of air outof the cap and into the atmosphere.

According to yet another aspect of the invention, a cap assembly for aself-priming IV set valve comprises a body portion that is configured tobe removably connected to the IV set valve. An actuator has a fixed endthat is mounted to the body portion and a free end that is configured toeither puncture, move or displace a valve element of the IV set valve. Ahydrophobic filter is mounted to the actuator. A chamber is disposed inthe body portion between the free end of the actuator and thehydrophobic filter. When the cap assembly is mounted to the IV setvalve, the hollow actuator tube either punctures, moves or displaces thevalve element of the IV set valve such that air and liquid within the IVset valve can flow at least partially through the actuator and into thechamber of the cap assembly, whereupon the hydrophobic filter of the capassembly prevents the passage of liquid through the hydrophobic filterwhile the hydrophobic filter permits the passage of air there-throughand into the atmosphere.

According to yet another aspect of the invention, a connector of aself-priming IV set valve comprises a connector body including a hollowregion; and a valve element that is at least partially positioned in thehollow region that is configured to be either moved or punctured by acap that is releasably connectable to the connector body. When the capis mounted to the connector, the cap either punctures or moves the valveelement and a passageway is formed in the connector such that air andliquid are permitted to pass through the connector and into the cap.When the cap is not mounted to the connector, the valve element of theconnector is configured to open under pressure to permit the passage ofliquid through the connector and close when pressure ceases.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

The invention is best understood from the following detailed descriptionwhen read in connection with the accompanying drawing. Included in thedrawing are the following figures:

FIG. 1A depicts a cross-sectional side elevation view of an IV set valveincluding a vented end cap assembly that is releasably mounted to aconnector according to a first exemplary embodiment of the invention,and FIG. 1B depicts the connector of FIG. 1A without the vented end capassembly.

FIG. 2A depicts a cross-sectional side elevation view of another IV setvalve according to a second exemplary embodiment of the invention, andFIG. 2B depicts the connector of FIG. 2A without the vented end capassembly.

FIG. 3A depicts a cross-sectional side elevation view of yet another IVset valve according to a third exemplary embodiment of the invention,and FIG. 3B depicts the connector of FIG. 3A without the vented end capassembly.

FIG. 4A depicts a cross-sectional side elevation view of still anotherIV set valve according to a fourth exemplary embodiment of theinvention, and FIG. 4B depicts the connector of FIG. 4A without thevented end cap assembly.

FIG. 5A depicts a cross-sectional side elevation view of still anotherIV set valve according to a fifth exemplary embodiment of the invention,and FIG. 5B depicts the connector of FIG. 5A without the vented end capassembly.

FIG. 6A depicts a perspective view of the cap assembly of FIGS. 1A, 2A,3A and 4A.

FIG. 6B depicts a top plan view of the cap assembly of FIG. 6A.

FIG. 6C depicts a cross-sectional view of the cap assembly of FIG. 6Btaken along the lines 6C-6C.

FIG. 7 depicts a cross-sectional side elevation view of still another IVset valve including a vented end cap assembly that is releasably mountedto a connector according to a sixth exemplary embodiment of theinvention.

DETAILED DESCRIPTION OF THE DRAWING FIGURES

The invention is best understood from the following detailed descriptionwhen read in connection with the accompanying drawing figures, whichshows exemplary embodiments of the invention selected for illustrativepurposes. The invention will be illustrated with reference to thefigures. Such figures are intended to be illustrative rather thanlimiting and are included herewith to facilitate the explanation of thepresent invention.

As used herein, the term ‘underinfusion’ generally refers to infusion offluid into a patient at a rate lower than intended.

As used herein, the term ‘overinfusion’ generally refers to infusion offluid into a patient at a rate higher than intended.

As used herein, the term ‘uncontrolled flow’ refers to the flow of fluidthrough the set without control, e.g., according to the law of physics.

As used herein, the term ‘freeflow’ generally refers to uncontrolledflow through a set that is connected to the patient. Freeflowencompasses underinfusion and overinfusion while correct flow underfreeflow condition is unlikely.

As used herein, the term ‘self-priming’ generally refers to venting ofthe set that does not require any interference from either a person or amachine.

As used herein, the term ‘pump priming’ generally refers to venting ofthe set under control of an infusion pump after being inserted into thelatter.

As used herein, the term ‘anti-freeflow’ generally refers to any measurethat prevents or stops freeflow.

Turning now to FIG. 6 of U.S. Pat. No. 5,954,696 to Ryan, an infusionset, indicated generally at 80, is adapted for use with the ambulatoryinfusion pump. As illustrated in FIG. 6 of the '696 Patent, the infusionset 80 generally comprises clear, flexible, medical grade tubing 82. Abag spike 22 is mounted at a proximal end (i.e., proximal to the IV bag)of the tubing 82 and a conventional Luer-type medical connector 84 ismounted at a distal end of the tubing 82. A check valve 86 is mounted tothe tubing 82 to prevent “flashback” when, for example, the infusionpump is turned-off, the cover opened, and the system depressurizes. Anair eliminating filter 88 of a type well understood in the art and aflow controlling resistive lumen or orifice 101, positioned immediatelyupstream to the Luer fitting 84, are also mounted to the tubing 82.

Referring generally to the Figures, the five inventive IV set valvesdescribed hereinafter may be used as a substitute for Ryan's Luer-typemedical connector 84 that is mounted at the distal end of the IV settubing 82, as shown in FIG. 6 of the '696 Patent. Each IV set valveembodiment disclosed herein includes a connector (such as a Luerconnector) and a vented cap that is releasably mounted to the connector.The vented cap may have a hydrophobic filter to allow air to be purgedfrom the IV set but not fluid. Mounting the cap to the connector createsa fluid passageway between the cap and the connector to allow air andfluid to pass into the cap during an air purge. Removing the cap fromthe connector closes the fluid passageway, thereby preventing fluid fromexiting the IV set. A valve element that is positioned inside theconnector is designed to open under pump pressure and close whenpressure ceases. In the event that the IV set is removed from the pumpor dislodged from the pumping mechanism by an open door, etc., flowthrough the valve element will not be possible if the cap is removed(i.e., no gravity flow will be possible).

Referring now the first embodiment of the IV set valve 10 shown in FIG.1A, the IV set valve 10 includes a connector 12 and a vented end capassembly 14 that is releasably mounted to the connector 12. The IV setvalve 10 may or may not be permanently mounted to an IV set (not shown).The vented cap assembly 14 is shown mounted to the connector 12 in FIG.1A, and the vented cap assembly 14 is shown removed from the connector12 in FIG. 1B. As will be described later, the vented cap assembly 14may also be used with other connectors that are shown herein.

According to one aspect of the invention, the connector 12 of the IV setvalve 10 is a male Luer connector, however, it should be understood thatthe connector 12 is not limited to being either a Luer connector or amale Luer connector, as other types of medical connectors areenvisioned.

Turning now to the features of the male Luer connector 12, the male Luerconnector 12 generally includes a two-piece hollow body 24 and a valveelement 28 that is non-removably mounted at the interface 30 of the twopieces of the connector 12. The pieces of the hollow body 24 are fixedto each other at interface 30 by either an adhesive or an ultrasonicweld, for example.

The top piece of the hollow body 24 includes a tubular shaped proximalend 26 defining a fluid passageway. The tubular shaped proximal end 26has a hollow chamber 36 in which fluid from the IV bag can collect. Thebottom piece of the hollow body 24 is a Luer connector comprising afrustoconical portion 17 defining a fluid passageway, and a shroud 64having internal female threads that surrounds the frustoconical portion17. The female threads of the shroud 64 are configured for coupling withmating threads of either the end cap assembly 14 (as shown in FIG. 1A)or a female Luer connector (not shown).

The valve element 28 of the connector 12 is biased toward a closedposition (as shown in FIG. 1B). In the absence of pressure or theactuator 16 of the cap assembly 14, the valve element 28 prevents thepassage of gases and liquid there through. In the presence of either theactuator 16 (as shown in FIG. 1A) or pressurized fluid produced byeither gravity or an infusion pump, the valve element 28 opens to permitthe passage of gases and liquid there through. The valve element 28 isalso configured to prevent siphoning of fluid from the IV bag. The valveelement 28 may also be referred to herein as a valve, a valve element,or a seal.

FIGS. 6A-6C depict the vented end cap assembly 14 that is configured tobe releasably connected to the connectors 12, 46, 62 and 92 of FIGS. 1B,2B, 3B and 4B, respectively. The vented end cap assembly 14 may or maynot be pre-mounted onto the distal end of the connector 12. Referringnow to the components of the vented end cap assembly 14, the assembly 14generally includes a body portion 18 defining an annular fluidpassageway 20, and a hydrophobic filter 19 that is mounted to the baseend of the body portion 18. Fluid passageway 20 may also be referred toherein as a fluid chamber.

The body portion 18 includes an actuator 16 that extends upwardly fromthe base end of the body portion 18. The actuator 16 has a three pointstar shape in cross-section. A series of three recessed semi-circularregions 16 a are evenly distributed about the circumference of theactuator 16. Each region 16 a extends from the tip at the free end 34 ofthe actuator 16 to the fixed end of the actuator 16. Each recessedregion 16 a extends the length of the actuator 16. As will be describedlater, the recessed regions 16 a form part of the fluid passageway ofthe vented end cap assembly 14.

The fluid passageway 20 of the end cap assembly 14 has three passagewayportions 20 a-20 c. The annular portion 20 a of the fluid passageway 20is sized to at least partially receive the frustoconical end 17 of themale Luer connector 12. The passageway portion 20 b comprises a seriesof openings that are defined between ribs 18 b of the body portion 18(see FIG. 6B). The portion 22 c of the fluid passageway 20 is sized toreceive the hydrophobic filter vent 19.

The hydrophobic filter vent 19 is especially configured to allow thepassage of air there through, while at the same time substantiallypreventing or limiting the passage of liquid there through. Thehydrophobic filter vent 19 may be composed of a hydrophobic porousmaterial such as Teflon, Polysulfone or glass fiber media. Such filtersare distributed by the Pall Corporation of Port Washington, N.Y., USA.

The body portion 18 of the cap assembly 14 may be composed of either aplastic or a metallic material. The body portion 18 may be formed byinjection molding or die casting, for example. The body portion 18 mayor may not be coated with a hydrophobic substance and or anantimicrobial compound.

To prime an IV set including the valve 10, one end of an IV set isconnected to the proximal end 26 of the valve 10, and the other end ofthe IV set is fluidly connected to an IV bag (not shown). The end capassembly 14 is fitted onto the distal end of the male Luer connector 12of the valve 10 for self-priming purposes. As the end cap assembly 14 isfitted onto the male Luer connector 12, the top end 34 of the actuator16 penetrates the opening 28 a (see FIG. 1A) of the valve 28.

By the force of gravity, fluid flows from the IV bag and into the IVset. The fluid within the IV set travels through the tubing of the IVset, and into the chamber 36 of the male Luer connector 12. As shown bythe arrows in FIG. 1A, any air within the tubing is also urged throughthe tube and into the chamber 36 of the male Luer connector 12. Theliquid and air within the chamber 36 then travel through the valveopening 28 a, down and along the recessed regions 16 a of the actuator16, and into the fluid passageway 20 of the cap assembly 14 that isdelimited by the hydrophobic filter vent 19. The fluid then collects onthe hydrophobic filter vent 19. The air passes through the hydrophobicfilter vent 19, while the liquid remains in the passageway 20 on top ofthe hydrophobic filter vent 19. At this point, the IV set is self-primedand free of air.

Once the air is purged from the IV set, the cap assembly 14 is removedfrom the male Luer connector 12. The valve 28 returns to a closedposition once the actuator 16 is removed from the Luer connector 12. Thedistal end of the male Luer connector 12 is then either directly orindirectly connected to a catheter that is connected to a patient'svascular system. The liquid from the IV bag is then delivered underpressure through the IV set by an infusion pump that is connected to theIV set. The pressurized liquid opens the opening 28 a of the valve 28,and the liquid is expelled from the male Luer connector 12 and isultimately distributed intravenously to the patient by the catheter.

FIG. 2A depicts a cross-sectional side elevation view of another IV setvalve 40 according to a second exemplary embodiment of the invention.The IV set valve 40 generally includes a male Luer connector 46 (shownby itself in FIG. 2B) and the previously-described end cap assembly 14.The IV set valve 40 is substantially similar to the set valve 10 of FIG.1, and only the primary differences between those valves will bedescribed hereinafter.

The IV set valve 40 includes a slit disc 42. The slit disc 42 may alsobe referred to herein as a valve, a valve element, or a seal. As bestshown in the detailed view to the right of FIG. 2, the slit disc 42includes normally-closed radial slits 43 that open to permit the passageof pressurized liquid. The slit disc 42 is movably positioned in anenlarged chamber 44 of the male Luer lock connector 46.

To prime an IV set including the valve 40, the IV set is fluidlyconnected to the IV bag (not shown). The end cap assembly 14 is fittedonto the male Luer connector 46. As the end cap assembly 14 is fittedonto the male Luer connector 46, the actuator 16 pushes the slit disc 42away from the shoulder 52 (i.e., the valve seat) of the male Luerconnector 46 and into the enlarged chamber 44 of the male Luer lockconnector 46.

By the force of gravity, liquid is urged out of the IV bag, through thetubing of the IV set, and into the enlarged chamber 44 of the male Luerconnector 46. Any air within the tubing is also urged through the tubeand into the chamber 44 of the male Luer connector 46. The liquid andair within the chamber 44 then travel past the tilted disc 42, throughthe chamber 40 of the connector 46, and into the passageway 20 of theend cap assembly 14. The air passes through the hydrophobic filter vent19, while the liquid remains in the passageway 20 of the end capassembly 14. At this point, the IV set is self-primed and free of air.

Once the air is purged from the IV set, the cap assembly 14 is removedfrom the male Luer connector 46, and the disc 42 comes to rest againstthe shoulder 52 of the male Luer connector 46 (as shown in FIG. 2B). Thedistal end of the male Luer connector 46 is then either directly orindirectly connected to a catheter that is intravenously connected to apatient. The liquid from the IV bag is then delivered under pressurethrough the IV set by an infusion pump that is connected to the IV set.The pressurized liquid causes the radial slits 43 of the valve 42 toopen, and the liquid is expelled from the male Luer connector 46 and isultimately distributed intravenously to the patient by the catheter.

FIG. 3A depicts a cross-sectional side elevation view of yet another IVset valve 60 according to a third exemplary embodiment of the invention.The IV set valve 60 generally includes a male Luer connector 62 (shownby itself in FIG. 3B) and the previously-described end cap assembly 14.The IV set valve 60 is substantially similar to the IV set valve 40 ofFIG. 2A, and only the primary differences between those valves will bedescribed hereinafter.

The housing 72 of the male Luer connector 62 includes two portions 72 aand 72 b that are fixed to each other at interface 72 c by either anadhesive or an ultrasonic weld, for example. A two-piece cage 68 ismovably positioned in an annular recess 70 that is defined by opposingcylindrical walls of the housing portion 72 b of the male Luer connector62. The cage 68 translates in a vertical fashion within the annularrecess 70. The cage 68 includes a central cage part 68 a and acup-shaped cage part 68 b.

The central cage part 68 a includes a central recess on its bottom endin which the free end of the actuator 16 is movably positioned. Thecentral cage part 68 a also includes a series of openings 68 c throughwhich liquid and gas may pass, as will be described later.

The cup-shaped cage part 68 b includes a series of openings 76. Theopening 76 are provided in a side wall of the cup-shaped cage part 68 bthrough which liquid and gas may pass. The openings 76 register with thesurface 80 of the interior cylindrical wall 82 to either permit orprevent the passage of fluid through the openings 76. More particularly,when the openings 76 are positioned at an elevation above the surface80, as shown, fluid can pass through the openings 76. In contrast, whenthe openings 76 are positioned at an elevation below the surface 80, asshown in FIG. 3B, fluid can not pass through the openings 76.

A deformable disc 78 is mounted to an opening 73 that is defined on thetop surface of the cage part 68 b. Although not shown, the disc 78deforms when it is exposed to pressurized fluid, thereby permittingliquid and gas to flow over the top surface of the deformed disc 78 andthrough the opening 73. The disc 78 returns to its original shape in theabsence of pressure. The deformable disc 78 may also be referred toherein as a valve, a valve element, or a seal.

As shown in FIG. 3A, when the end cap assembly 14 is fitted onto themale Luer connector 62, the free end of the actuator 16 bears on thecentral cage part 68 a and translates the entire cage 68 in an upwarddirection. After the cage 68 has translated a pre-determined amount, theopenings 76 in the cage 68 rise above the top surface 80 of the wall 82.Once the openings 76 are exposed, liquid and gas may pass through theopenings 76 and into the chamber 83 b.

To prime an IV set including the valve 60, the IV set is fluidlyconnected to the IV bag (not shown). The end cap assembly 14 is fittedonto the distal end of the male Luer connector 62. As the end capassembly 14 is fitted onto the male Luer connector 62, the free end ofthe actuator 16 pushes the cage 68 upwards such that the openings 76rise above the top surface 80 of the wall 82, as shown in FIG. 3A.

By the force of gravity, liquid is urged out of the IV bag, through thetubing of the IV set, and into the chamber 83 a of the male Luerconnector 62. Any air within the tubing is also urged through the tubeand into the chamber 83 a of the male Luer connector 62. The liquid andair within the chamber 83 a then travel between the cage 68 and thehousing portion 72 a, and enter the openings 76 of the cage 68. Theliquid and air collect in the chamber 83 b of the housing portion 72 band ultimately enter the passageway 20 of the end cap assembly 14 undergravity. The air passes through the hydrophobic filter 19, while theliquid remains in the passageway 20 above the hydrophobic filter 19. Atthis point, the IV set is self-primed and free of air.

Once the air is purged from the IV set, the end cap assembly 14 isremoved from the male Luer connector 62, and the cage 68 translatesdownward such that the openings 76 of the cage 68 are concealed withinthe annular recess 70. The distal end of the male Luer connector 62 isthen either directly or indirectly connected to a catheter that isintravenously connected to a patient. The liquid from the IV bag is thendelivered under pressure through the IV set by an infusion pump that isconnected to the IV set. The pressurized liquid causes the disc 78 todeform (deformation not shown) and the liquid flows over the deformedtop surface (not shown) of the disc 78 and through the opening 73 in thecage part 68 b. The liquid then flows through the openings 68 c in thecage part 68 a and into the chamber 83 b of the housing portion 72 b.The liquid is expelled from the male Luer connector 62 through thefrustoconical portion 17 and is ultimately distributed intravenously tothe patient by the catheter (not shown) that is connected to theconnector 62. The disc 78 returns to its natural position shown in FIG.3B in the absence of pressure.

FIG. 4A depicts a cross-sectional side elevation view of still anotherIV set valve 90 according to a fourth exemplary embodiment of theinvention. The IV set valve 90 generally includes a male Luer connector92 (shown by itself in FIG. 4B) and the previously-described end capassembly 14. The IV set valve 90 is substantially similar to the IV setvalve 40 of FIG. 2A, and only the primary differences between thosevalves will be described hereinafter.

The male Luer connector 92 includes a housing 91 that is comprised of anupper housing portion 91 a that is fixedly mounted to a lower housingportion 91 b at interface 91 c. A series of flow channels 102 areprovided on the interior side wall of the housing 91. The flow channels102 are defined between adjacent ribs 99 that are provided on surfacesof the upper housing portion 91 a.

A chamber 103 is defined in the housing 91 in which a seal 93 is movablypositioned. The seal 93 can translate between a lower elevation whereits lower surface contacts a bottom surface 98 (otherwise referred to asa valve seat) of the chamber 103, and a higher elevation where the uppersurface of the seal 93 contacts the ribs 99.

As shown in FIG. 4B, when the seal 93 is positioned against the bottomsurface 98 of the chamber 103, the seal 93 prevents the inadvertentpassage of liquid and gas into the chamber 105. However, when the seal93 is separated from the bottom surface 98 of the lower housing portion91 b, the seal 93 permits the passage of liquid and gas into the chamber105. The seal 93 may also be referred to herein as a valve or a valveelement.

The seal 93 includes a flexible upper seal member 95 that is fixedlymounted to a rigid support member 96 that is optionally composed ofplastic. A slit 97 is defined on the flexible seal member 95. Althoughnot shown, the slit 97 opens when it is exposed to pressurized fluid,thereby permitting liquid and gas to flow through the slit 97 of theseal 93. As shown in FIG. 4B, the rigid plastic support member 96 of theseal 93 includes an outer portion 96 b, a central portion 96 c, and oneor more openings 96 d that are defined between those portions 96 b and96 c. The openings 96 d provide a passage through which liquid and gasmay flow into the chamber 105.

To prime an IV set including the valve 90, the proximal end 92 a of theconnector 92 is connected to one end of the IV set, and the other end ofthe IV set is fluidly connected to the IV bag (not shown). The end capassembly 14 is fitted onto the distal end of the male Luer connector 92.As the end cap assembly 14 is fitted onto the male Luer connector 92,the actuator 16 pushes the seal 93 upwards thereby separating the seal93 from the bottom surface 98 of the lower housing portion 91 b.

By the force of gravity, liquid is urged out of the IV bag, through thetubing of the IV set, and into the chamber 103 of the male Luerconnector 92. Any air within the tubing is also urged through the tubeand into the chamber 103 of the male Luer connector 92. The liquid andair within the chamber 103 then travel through the gap (see FIG. 4A)between the bottom end of the seal 93 and the bottom surface 98 of thelower housing portion 91 b. The liquid and air collect in the chamber105 defined by the frustoconical portion of the Luer connector andultimately enter the passageway 20 of the end cap assembly 14. The airpasses through the hydrophobic filter vent 19, while the liquid remainsin the passageway 20 of the end cap assembly 14 above the hydrophobicfilter vent 19. At this point, the IV set is self-primed and free ofair.

Once the air is purged from the IV set, the end cap assembly 14 isremoved from the male Luer connector 92, and the seal 93 translatesdownward such that the bottom end of the seal 93 re-seats on the bottomsurface 98 of the lower housing portion 91 b. The distal end 92 b of themale Luer connector 92 is then either directly or indirectly connectedto a catheter (not shown) that is intravenously connected to a patient.The liquid from the IV bag is then delivered under pressure through theIV set by an infusion pump that is connected to the IV set. Thepressurized liquid causes the slit 97 of the seal 93 to open and theliquid flows through the slit 97, through the openings 96 d of thesupport member 96, and the liquid is expelled from the male Luerconnector 92 and is ultimately distributed intravenously to the patientby the catheter (not shown) that is connected to the connector 92. Theslit 97 of the seal 93 returns to its natural position shown in FIG. 4Ain the absence of pressure.

FIG. 5A depicts a cross-sectional side elevation view of still anotherIV set valve 110 according to a fifth exemplary embodiment of theinvention. The IV set valve 110 generally includes a male Luer connector112 (shown by itself in FIG. 5B) and an end cap assembly 114. The IV setvalve 110 is substantially similar to the IV set valve 60 of FIG. 3A,and only the primary differences between those valves will be describedhereinafter.

The male Luer connector 112 includes a housing 116 that is comprised ofa top housing portion 116 a that is fixedly mounted to a lower housingportion 116 b at interface 116 c. A series of flow channels 118 areprovided on the interior side wall of the housing 116 a through whichfluid may pass.

A spring-loaded piston 120 is movably positioned within a chamber 122 ofthe lower housing part 116 b. A series of openings 120 a are provided inthe piston 120, through which fluid may pass. A threaded aperture 120 bis defined on the lower surface of the piston 120.

A movable seal 121 is positioned above the spring-loaded piston 120. Themovable seal 121 moves between a floating position (see FIG. 5A) and aseated position (see FIG. 5B). In the floating position, the seal 121 issurrounded by ribs 119 that project from the interior surface of theupper housing part 116 a. A series of openings 118 are defined betweenadjacent ribs 119 so that fluid may pass over the surface of the seal121 and through the openings 118. In the seated position of the seal121, the top surface of the seal 121 is seated against a valve seat 130that is formed on the upper housing part 116 a.

The piston 120 can translate between a lower elevation where it contactsa bottom surface 127 (see FIG. 5B) of the chamber 122, and a higherelevation where the top end of the piston 120 contacts and deforms theseal 121, as shown in FIG. 5B.

As shown in FIG. 5B, when the seal 121 is positioned against the valveseat 130, the seal 121 prevents the inadvertent passage of liquid andgas into the chamber 122 of the connector 112. However, when the seal121 is separated from the valve seat 130, as shown in FIG. 5A, the seal121 permits the passage of liquid and gas into the chamber 122 via theopenings 118. The seal 121 may also be referred to herein as a valve ora valve element.

The end cap assembly 114 is similar to the end cap assembly 14 withvarious exceptions. The end 134 of the actuator 132 is threaded so thatit can engage the threaded aperture 120 b of the piston 120. A series ofopenings 136 are provided at the base of the actuator 132 to permit thepassage of fluid. A hydrophobic filter vent 138 is mounted to the bottomend of the end cap assembly 114 at an elevation below the openings 136.

To prime an IV set including the valve 110, one end of the IV set isconnected to the proximal end 112 a of the connector 112 and the otherend of the IV set is fluidly connected to the IV bag (not shown). Theend cap assembly 114 is fitted onto the distal end 112 b of the maleLuer connector 112. As the end cap assembly 114 is threaded onto theshroud 64 of the male Luer connector 112, the threaded end 134 of theactuator 132 simultaneously engages the threaded aperture 120 b of thepiston 120, thereby pulling the spring loaded piston 120 in a downwarddirection (see FIG. 5A). The seal 121 then separates from the valve seat130 by gravity.

As depicted by the arrows in FIG. 5A, by the force of gravity, liquid isurged out of the IV bag, through the tubing of the IV set, and into thechamber 140 of the male Luer connector 112. Any air within the tubing isalso urged through the tube and into the chamber 140 of the male Luerconnector 112. The liquid and air within the chamber 140 then travelpast the seal 121, through the openings 118 formed in the upper housingpart 116 a, through the openings 120 a of the piston 120, through theannular fluid passageway 150 that is formed around the actuator 132,through the openings 136 formed at the base of the actuator 132. The airpasses through the hydrophobic filter vent 138, while the liquid remainsin the openings 136 and the fluid passageway 150. At this point, the IVset is self-primed and free of air.

Once the air is purged from the IV set, the end cap assembly 114 isremoved from the male Luer connector 112, and the spring loaded piston120 moves upward and urges the seal 121 against the valve seat 130, asshown in FIG. 5B. The distal end 112 b of the male Luer connector 112 isthen either directly or indirectly connected to a catheter (not shown)that is intravenously connected to a patient. The liquid from the IV bagis then delivered under pressure through the IV set by an infusion pumpthat is connected to the IV set. The pressurized liquid causes the edgesof the seal 121 to separate from the valve seat 130. The pressurizedliquid then flows over the seal 121, through the openings 120 a of thepiston 120, through the fluid passageway 150, and the liquid is expelledfrom the male Luer connector 112 and is ultimately distributedintravenously to the patient by the catheter (not shown) that isconnected to the connector 112. The seal 121 returns to its naturalposition shown in FIG. 5B in the absence of pressure.

FIG. 7 depicts a cross-sectional side elevation view of still another IVset valve 210 according to a sixth exemplary embodiment of theinvention. The IV set valve 210 includes a connector 212 and a ventedend cap assembly 214 that is releasably mounted to the connector 212.The IV set valve 210 may or may not be permanently mounted to an IV set(not shown).

The end cap assembly 214 is friction fitted onto the frustoconicalportion 217 of the male Luer connector 212. Although not shown, the maleLuer connector 212 may include a shroud (like shroud 64 of FIG. 1A)having female threads that surrounds the frustoconical portion 217 ofthe male Luer connector 212 for coupling with a female Luer connector(not shown). If the male Luer connector 212 includes such a threadedshroud, then the end cap assembly 214 may optionally include a male Luerthread for threadedly mating with the female threads of the threadedshroud of the male Luer connector 212.

Referring now to the components of the end cap assembly 214, the end capassembly 214 generally includes a body portion 218 defining a steppedbore 220, a hydrophobic filter vent 219 that is non-removably mounted inthe stepped bore 220, and an actuator tube 216 that is non-removablymounted in the stepped bore 220 and is positioned to extend in an upwarddirection toward the male Luer connector 212. The cap assembly 214 mayor may not be coated with a hydrophobic substance and or anantimicrobial compound. The cap assembly 214 may or may not bepre-mounted onto the distal end of the connector 212.

The body portion 218 has a hollow revolved body that is composed ofeither a plastic or a metallic material. The stepped bore 220 has fourportions 220 a-220 d. The portion 220 a is sized to receive thefrustoconical end 217 of the male Luer connector 212. The portion 220 bis sized to receive the actuator tube 216. The portion 220 c is sized toreceive the hydrophobic filter vent 219. The portion 220 d defines thechamber 238 in which the pooled fluid collects.

The actuator tube 216 is a hollow tube that is open at both ends. Theactuator tube 216 is composed of either a plastic or a metallicmaterial. The actuator tube 216 may be insert molded with the bodyportion 218. Alternatively, the actuator tube 216 may be mounted to thebody portion 218 by an adhesive or an ultrasonic weld, for example.

Turning now to the features of the male Luer connector 212, the maleLuer connector 212 includes a hollow body 224 including a tubular shapedproximal end 226 and the frustoconical portion 217 that extends in adistal direction. The tubular shaped proximal end 226 has a hollowchamber 236 in which fluid from the IV bag can collect. A valve element228 is seated on a shoulder 230 (otherwise referred to as a valve seat)of the tubular portion 226 and extends into a recess 232 that is definedin the frustoconical portion 217 of the Luer connector 212. The valveelement 228 may also be referred to herein as a valve, a valve element,a duckbill valve, or a seal.

The duckbill valve 228 is biased toward a closed position, and, in theabsence of pressure or the actuator tube 216, the duckbill valve 228prevents the passage of gases and liquid there through. In the presenceof either the actuator tube 216 or pressurized fluid produced by gravityor an infusion pump, the duckbill valve 228 opens (open configurationnot shown) to permit the passage of gases and liquid there through. Theduckbill valve 228 is also configured to prevent siphoning of fluid fromthe IV bag. A duckbill valve is disclosed in U.S. Pat. No. 6,092,551 toBennett, which is incorporated by reference herein in its entirety.

To prime an IV set including the valve 210, one end of the IV set isconnected to the proximal end of the valve 210, the and the other end ofthe IV set is fluidly connected to the IV bag (not shown). The end capassembly 214 is fitted onto the frustoconical portion 217 of the maleLuer connector 212 of the valve 210 for self-priming purposes.

As the end cap assembly 214 is fitted onto the male Luer connector 212,the actuator tube 216 penetrates the opening (not shown) provided on thebottom end of the duckbill valve 228. Once the end cap assembly 214 isfitted onto the male Luer connector 212, the top open end 234 of theactuator tube 216 resides above the duckbill valve 228 and is positionedin the chamber 236 of the male Luer connector 212. The actuator tube 216fluidly connects the chamber 236 of the tubular portion 226 of the maleLuer connector 212 with the chamber 238 of the end cap assembly 214.

By the force of gravity, fluid within the IV set travels through thetubing of the IV set, and into the chamber 236 of the male Luerconnector 212. Any air within the tubing is also urged through the tubeand into the chamber 236 of the male Luer connector 212. The liquid andair within the chamber 236 then travel through the exposed open end 234of the actuator tube 216, through the actuator tube 216 and into thechamber 238 of the end cap assembly 214 that is delimited by thehydrophobic filter vent 219. The fluid then collects on the hydrophobicfilter vent 219. The air passes through the hydrophobic filter vent 219,while the liquid remains above the hydrophobic filter vent 219 in thechamber 238. At this point, the IV set is self-primed and free of air.

Once the air is purged from the IV set, the cap assembly 214 is removedfrom the male Luer connector 212. The duckbill valve 228 returns to aclosed position once the actuator tube 216 is removed from the Luerconnector 212. The distal end of the male Luer connector 212 is theneither directly or indirectly connected to a catheter that is connectedto a patient's vascular system. The liquid from the IV bag is thendelivered under pressure through the IV set by an infusion pump that isconnected to the IV set. The pressurized liquid causes the duckbillvalve 228 to open, and the liquid is expelled from the male Luerconnector 212 and is ultimately distributed intravenously to the patientby the catheter.

While preferred embodiments of the invention have been described herein,it will be understood that such embodiments are provided by way ofexample only. Numerous variations, changes and substitutions will occurto those skilled in the art without departing from the spirit of theinvention. It is intended that the appended claims cover all suchvariations as fall within the spirit and scope of the invention.

What is claimed:
 1. A method of priming an IV set that is connected toan IV bag, the IV set including a vented cap having an actuator and aconnector having an opening through which fluid is expelled from theconnector, said method comprising the steps of: connecting the ventedcap to the connector by positioning the actuator through the opening ofthe connector; delivering fluid, including air and liquid, through theIV set, into the connector, along a surface of the actuator that ispositioned through the opening, through the opening of the connector,into the cap and onto a hydrophobic filter of the cap; and permittingthe passage of air through the hydrophobic filter, out of the cap andinto the atmosphere and wetting the hydrophobic filter to prevent thepassage of liquid.
 2. The method of claim 1, wherein the connecting stepcomprises inserting the actuator of the cap, which extends from thehydrophobic filter of the cap, through a frustoconical portion of theconnector to contact the valve element thereby creating a fluidpassageway between the connector and the cap.
 3. The method of claim 1,wherein the connecting step comprises inserting the actuator of the capthrough a valve element of the connector thereby creating a fluidpassageway between the connector and the cap.
 4. The method of claim 1,wherein the connecting step comprises inserting the actuator of the capinto the connector to displace a valve element away from a valve seat ofthe connector thereby creating a fluid passageway between the connectorand the cap.
 5. The method of claim 4, wherein the delivering stepcomprises delivering fluid between the valve element and the valve seat,through an opening disposed in the actuator, through the actuator, andonto the filter.
 6. The method of claim 1 further comprising the stepsof connecting the IV set to an infusion pump, removing the cap from theconnector, and activating the infusion pump.
 7. The method of claim 6,wherein the activation step causes a valve element within the connectorto open to permit the passage of fluid out of the connector.
 8. Themethod of claim 1, wherein the connecting step comprises inserting theactuator of the cap into the connector thereby moving a cage that ismoveably positioned in the connector to create a portion of the fluidpassageway between the connector and the cap without deforming the valveelement.
 9. The method of claim 8, wherein upon moving the cage, theportion of the fluid passageway is defined between an opening in thecage and a wall of the connector.
 10. The method of claim 9, wherein thedelivering step comprises delivering fluid through the opening of thecage, and onto the filter.